Aerobic Exercise for Remyelination in Multiple Sclerosis

July 28, 2025 updated by: Lindsey Wooliscroft, Oregon Health and Science University

Aerobic Exercise to Improve Mobility in Multiple Sclerosis: Optimizing Design and Execution for a Full-scale Multimodal Remyelination Clinical Trial

This is a clinical trial to determine the feasibility of a stationary aerobic cycling intervention and explore if aerobic exercise independently promotes remyelination in people with multiple sclerosis (MS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Multiple sclerosis (MS) is the most common non-traumatic disabling neurologic condition of young adulthood, affecting more than 2.5 million people worldwide. Permanent disability in MS is caused by recurrent demyelination due to episodic inflammation, followed by neuronal damage, axonal degeneration, and progressive failure of remyelination. There is an urgent need to restore activity and participation in people with MS (pwMS), and remyelination is the most promising therapeutic strategy to accomplish this goal.

Remyelination in pwMS will likely require integration of pharmacologic and rehabilitative approaches to ensure effective remyelination of appropriate neural pathways. Aerobic exercise is an ideal complement to remyelinating medications because aerobic exercise 1) improves walking function in pwMS, and 2) promotes remyelination in animal models both independently and synergistically with medications. However, there are many unknowns that need to be addressed before aerobic exercise can be explored in multimodal clinical trials for remyelination. First, it is imperative to understand how myelination impacts disability in MS, as many other factors could contribute to reduced activity and participation. Additionally, as remyelination occurs over 12 to 24 weeks, it is imperative to establish the feasibility of similar duration of aerobic exercise interventions, and explore if exercise independently influences established remyelination outcomes before integration into multimodal strategies.

This is a randomized, single-blind, parallel clinical trial of a 24-week aerobic stationary cycling intervention to determine feasibility and explore if aerobic exercise independently promotes remyelination in pwMS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lindsey B Wooliscroft, MD, MSc, MCR
  • Phone Number: 503-494-5759
  • Email: wooliscr@ohsu.edu

Study Contact Backup

  • Name: Michelle Cameron, MD, PT, MCR
  • Phone Number: 503-494-5759
  • Email: cameromi@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Physician-confirmed diagnosis of MS based on the 2017 McDonald criteria
  • 18-64 years old
  • Have access to the internet and a device that can access virtual visits
  • (Inclusion criteria to advance to clinical trial) Somatosensory evoked potential (SSEP) latency z-score ≥2 for P40 or inter-side difference in z-score ≥2 for P40

Exclusion Criteria:

  • Medical or biophysical conditions that prohibit the use of a cycle ergometer or treadmill (medical readiness to be assessed by the Activity Readiness Questionnaire (PAR-Q)) or achievement of target heart rate.
  • Engages in >30 minutes/week of aerobic activity regularly.
  • Clinically confirmed MS relapse in the last 3 months.
  • Changes in disease modifying therapy (DMT) for MS in the last 6 months.
  • Pregnant women.
  • Treatment with steroids for MS in the last 30 days.
  • Concurrent use of 4-aminopyridine or dalfampridine (medications which can alter SSEP) and unwilling to discontinue it for 2 days prior to SSEP testing.
  • Have a known history of severe spinal canal stenosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MS: Cycle
Twenty-two participants in the clinical trial arm will be randomized to MS:Cycle: an aerobic exercise intervention on a stationary ergometer. Participants will exercise thrice weekly for 30 minutes with graded supervision for 24 weeks.
Behavioral: Aerobic exercise
Aerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks.
Active Comparator: MS: Take Control
Twenty-two participants in the clinical trial arm will be randomized to MS: Take Control (MSTC): a monthly, hour-long MS education control group led by a trained facilitator.
Behavioral: Education Group Control
A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Somatosensory Evoked Potentials (SSEPs)
Time Frame: From baseline to week 24
Measure of functional myelination of the somatosensory tracts of the spinal cord
From baseline to week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6-Minute Timed Walk (6MTW)
Time Frame: From baseline to week 24
An assessment of exercise tolerance
From baseline to week 24
Timed Up and Go (TUG)
Time Frame: From baseline to week 24
A test of walking agility
From baseline to week 24
Timed 25-Foot Walk (T25FW)
Time Frame: From baseline to week 24
A test of walking speed
From baseline to week 24
Fall frequency
Time Frame: From baseline to week 24
A self-report of fall frequency over the last 30 days
From baseline to week 24
9 Hole Peg Test
Time Frame: From baseline to week 24
A test of upper extremity and arm function
From baseline to week 24
Multiple Sclerosis Functional Composite (MSFC)
Time Frame: From baseline to week 24
Composite measure of walking speed, upper extremity function and cognition.
From baseline to week 24
Virtual aerobic exercise intervention adherence
Time Frame: From baseline to week 24
Defined as participation in at least 80% of the exercise sessions in the trial
From baseline to week 24
Virtual education control group adherence
Time Frame: From baseline to week 24
Defined as participation in at least 80% of the education group sessions in the trial
From baseline to week 24
Average heart rate (HR) zone during exercise sessions
Time Frame: From baseline to week 24
Average HR zone during exercise sessions
From baseline to week 24
Brain Myelin Water Fraction (MWF)
Time Frame: From baseline to week 24
MWF imaging of the corpus callosum, internal capsules and MS lesions
From baseline to week 24
Symbol Digit Modalities Test (SDMT)
Time Frame: From baseline to week 24
A test of cognitive function
From baseline to week 24
VO2 max
Time Frame: From baseline to week 24
A test of aerobic fitness
From baseline to week 24
7-site skinfold test
Time Frame: From baseline to week 24
A test of body composition
From baseline to week 24
Modified Fatigue Impact Scale (MFIS)
Time Frame: From baseline to week 24
A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue).
From baseline to week 24
Pain Effects Scale (PES)
Time Frame: From baseline to week 24
A patient reported outcome of pain with a range of 6-30 (higher scores indicate a greater impact of pain on a person's mood or behavior).
From baseline to week 24
Health-related quality of life (QoL)
Time Frame: From baseline to weeks 24
Neuro-QoL questionnaires of upper and lower extremity function, depression, sleep, and self efficacy
From baseline to weeks 24
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame: From baseline to week 24
A patient reported outcome of physical activity
From baseline to week 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Determined Disease Steps (PDDS)
Time Frame: Baseline
A patient reported outcome of MS disability ranging from 0-8 (with higher scores indicating increased disability).
Baseline
Activity Readiness Questionnaire (PAR-Q)
Time Frame: Baseline and 12 weeks
An assessment of safety to participate in exercise
Baseline and 12 weeks
6-Minute Timed Walk (6MTW)
Time Frame: From baseline to week 12
An assessment of exercise tolerance
From baseline to week 12
Timed Up and Go (TUG)
Time Frame: From baseline to week 12
A test of walking agility
From baseline to week 12
Timed 25-Foot Walk (T25FW)
Time Frame: From baseline to week 12
A test of walking speed
From baseline to week 12
Fall frequency
Time Frame: From baseline to week 12
A self-report of fall frequency over the last 30 days
From baseline to week 12
9 Hole Peg Test
Time Frame: From baseline to week 12
A test of upper extremity and arm function
From baseline to week 12
Multiple Sclerosis Functional Composite (MSFC)
Time Frame: From baseline to week 12
Composite measure of walking speed, upper extremity function and cognition.
From baseline to week 12
Symbol Digit Modalities Test (SDMT)
Time Frame: From baseline to week 12
A test of cognitive function
From baseline to week 12
Modified Fatigue Impact Scale (MFIS)
Time Frame: From baseline to week 12
A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue).
From baseline to week 12
Pain Effects Scale (PES)
Time Frame: From baseline to week 12
A patient reported outcome of pain with a range of 6-30 (higher scores indicate a greater impact of pain on a person's mood or behavior).
From baseline to week 12
Somatosensory Evoked Potentials (SSEPs)
Time Frame: From baseline to week 12
Measure of functional myelination of the somatosensory tracts of the spinal cord
From baseline to week 12
Strength testing
Time Frame: From baseline to week 24
Strength of the quadriceps, hamstrings, and hand grip is measured with dynamometers
From baseline to week 24
Strength testing
Time Frame: From baseline to week 12
Strength of the quadriceps, hamstrings, and hand grip is measured with dynamometers
From baseline to week 12
Health-related quality of life (QoL)
Time Frame: From baseline to weeks 12
Neuro-QoL questionnaires of upper and lower extremity function, depression, sleep, and self efficacy
From baseline to weeks 12
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame: From baseline to week 12
A patient reported outcome of physical activity
From baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
EMD Serono
Oregon Clinical and Translational Research Institute
Portland VA Medical Center
Medical Research Foundation, Oregon
Myelin Repair Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lindsey B Wooliscroft, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00021045
  • K23HD101667 (U.S. NIH Grant/Contract)
  • UL1TR002369 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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